Basic Principles and regulatory Practices Flashcards
What is phytotherapy?
The use of phytomedicines for health benefits including treatment and prevention of diseases.
What are phytomedicines?
Finished, labelled medicinal products that contain as active ingredients parts of plants or other plant material.
List the forms of plant-derived health/medicinal products.
- Powdered botanical crude drugs
- Traditionally used medicinal plants
- Non-standardized extracts
- Standardized extracts
- Pure compounds isolated from plants
What is the difference between medicines and supplements?
- Medicines: used for illness/diseases
- Supplements: used to improve health, may be recommended for certain conditions
What is the rationale for using extracts in phytomedicines?
- Seeking synergistic/additive effects
- Convenient administration of active material
- Greater stability than dry plant materials
- Preparation of standardized products
True or False: Phytomedicines administer a pure chemical.
False
Define synergy in the context of phytochemicals.
The action of a chemical mixture is greater than the arithmetical sum of the actions of the mixture’s components.
What are the two types of synergistic interactions for phytochemicals?
- Inactive phytochemicals that enhance effects
- All active phytochemicals in the mixture
What is polyvalent activity?
The range of biological activities that an extract may exhibit contributing to overall clinical effects.
What are the two main key levels at which polyvalent activity can occur?
- Many chemicals present, each exerting different bioeffects
- Phytochemicals of one type having multiple biological effects
What are the regulatory practices for herbal medicines in China?
- TCM products produced in pharmaceutical factories
- Equal status to Western pharmaceutical drugs
- Supervised by CFDA
How are herbal medicines regulated in India?
- By AYUSH
- By CDSCO
- Under D & C Act
What is the role of the European Medicines Agency (EMA) regarding herbal products?
Medicinal products, including herbal origin, are registered and controlled.
What are traditional herbal medicinal products (THMP)?
Registered without requiring documents on tests and trials on safety and efficacy.
What is the classification of dietary supplements under the FD&C Act in the USA?
Products intended to supplement the diet, containing vitamins, minerals, herbs, or other dietary ingredients.
What are the two categories of natural products regulated in Australia?
- Low-risk medicines
- High-risk medicines
Fill in the blank: In phytomedicines, _______ constituents serve to neutralize unwanted side effects.
bio-inactive
What is an example of a synergistic interaction in herbal extracts?
Consumption of fresh kiwi fruit juice resulting in greater ascorbate delivery than other methods.
True or False: Regulations for herbal products are consistent across all countries.
False
What is the significance of the WHO Traditional Medicine Strategy?
It aims to supply developing countries with appropriate medicinal products through local resources.
What is the classification of green tea in different countries?
- Classified as Medicines in Canada and Australia
- Classified as Supplements in China, New Zealand, and the EU
- Treated both as a supplement and drug in the USA
What is the impact of chemical complexity in phytomedicines?
It allows for multifaceted activity targeting various pharmacological effects.
What is the regulatory status of supplements in the USA compared to drugs?
Supplements are regulated through post-market surveillance, while drugs require proven safety and efficacy before approval.
What is the main reason for the lack of global consensus in product regulations?
Differences in regulatory definition and categorization of products between countries
This affects how products are classified and regulated worldwide.
How do regulatory requirements differ between products classified as Medicines and those classified as Supplements?
Regulatory requirements are usually consistent for Medicines, but vary significantly for Supplements across countries
This indicates that products can have different compliance standards based on their classification.
What should be promoted to ensure effective imparting in health care regarding herbal drugs?
Quality control, standardization, pharmacovigilance, and clinical trials on herbal products
These measures are essential for ensuring the safety and efficacy of herbal drugs.
True or False: Regulatory requirements for all products classified as Supplements are the same across all countries.
False
There is significant variability in the regulatory requirements for Supplements.
Fill in the blank: The lack of global consensus is mainly due to the _______ in regulatory definition and categorization of products.
difference
This highlights the challenges in achieving uniformity in regulations.
